I was recently invited to be part of a panel on the role of biopharmaceuticals in product liability litigation as part of ABA’s section on Litigation held in Boston: Current Issues in Pharmaceutical and Medical Device Litigation. The panel was moderated by Debra Perry of McCarter and English and my co-presenters were Krista Cosner of Drinker Biddle & Reath and and Maureen Bresnahan, in house counsel at Eisai, Inc.

Unlike traditional small molecule pharmaceuticals, biologics (including biosimilars) are large molecules, typically injected into the system that generally interact with the body in the blood stream or on the surface of cells. My presentation focused on the regulatory status of biopharmaceuticals as well their drug development, manufacturing and marketing challenges. Key amongst these are definitions of “similarity” and “interchangeability”. The simple rules followed for introduction and defense of generic “small molecule” drugs, including preemption, will no longer be valid. Planning during product development for future litigation risk is good business.

We believe that biosimilars will provide unique and complex challenges for product liability and regulatory lawyers in the years and decades to come.

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